Cost Effectiveness of Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension

Rod S Taylor; Anthony Bentley; Kaylie Metcalfe; Melvin D Lobo; Ajay J Kirtane; Michel Azizi; Christopher Clark; Kieran Murphy; Jennifer H Boer; Marjolijn van Keep; An Thu Ta; Neil C Barman; Garrett Schwab; Ron Akehurst; Roland E Schmieder

doi:10.1007/s41669-024-00472-z

Cost Effectiveness of Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension

Pharmacoecon Open. 2024 Jan 30. doi: 10.1007/s41669-024-00472-z. Online ahead of print.

Authors

Rod S Taylor¹, Anthony Bentley², Kaylie Metcalfe², Melvin D Lobo³, Ajay J Kirtane⁴, Michel Azizi^{5

6

7}, Christopher Clark⁸, Kieran Murphy⁹, Jennifer H Boer¹⁰, Marjolijn van Keep¹⁰, An Thu Ta¹⁰, Neil C Barman⁹, Garrett Schwab⁹, Ron Akehurst^{11

12}, Roland E Schmieder¹³

Affiliations

¹ MRC/CSO Social and Public Health Sciences Unit and Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, 90 Byres Rd, Glasgow, G12 8TB, UK. rod.taylor@glasgow.ac.uk.
² Mtech Access Limited, Bicester, Oxfordshire, UK.
³ Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK.
⁴ Columbia University Irving Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.
⁵ Université de Paris, Paris, France.
⁶ Hypertension Department and DMU CARTE, AP-HP, Hôpital Européen Georges-Pompidou, Paris, France.
⁷ INSERM, CIC1418, Paris, France.
⁸ Primary Care Research Group, University of Exeter Medical School, Exeter, UK.
⁹ ReCor Medical, Palo Alto, CA, USA.
¹⁰ BresMed Netherlands, Utrecht, The Netherlands.
¹¹ BresMed Health Solutions, Sheffield, UK.
¹² University of Sheffield, Sheffield, UK.
¹³ Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.

PMID: 38289517
DOI: 10.1007/s41669-024-00472-z

Abstract

Background: Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90 mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system.

Methods: Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP ('control' patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs).

Results: A mean reduction in office SBP of 8.5 mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (€6500) per QALY gained (95% confidence interval £5463-£5739 [€6341-€6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000-£30,000 (€23,214-€34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks.

Conclusions: Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication.